Study on DR-01 for Patients with Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas

Sponsor: Dren Bio

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05475925

Provider View

This clinical trial is testing a new drug, DR-01, to see if it is safe and effective for adults with large granular lymphocytic leukemia or cytotoxic lymphomas. The study will look at how the drug works in the body and its ability to fight cancer.

Patient Parameters

Program Overview

This study is the first of its kind to test DR-01 in humans. It aims to evaluate the safety, tolerability, and effectiveness of DR-01 in treating adults with large granular lymphocytic leukemia or cytotoxic lymphomas. Researchers will also study how the drug behaves in the body and its impact on tumors.

Eligibility Criteria

Exclusion Criteria

  • Have a type of large granular lymphocytic leukemia linked to a viral infection or certain blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
  • Have an active infection that requires treatment with antibiotics, antivirals, or antifungals.
  • Have cancer that has spread to the brain or spinal cord.
  • Have severe complications from cancer, such as uncontrolled bleeding or severe infections.
  • Have another active cancer.
  • Have HIV or active hepatitis B or C infections. However, those with treated hepatitis C and no detectable virus can participate.
  • Have significant heart disease or heart failure beyond a certain level.
  • Are using certain steroid medications or other immune-suppressing drugs recently, unless for specific conditions.
  • Require hormonal therapy for conditions other than contraception or hormone replacement.
  • Have any medical or psychiatric condition that could increase the risk of participating in the study.
  • Have unresolved side effects from previous cancer treatments, except for hair loss or mild nerve damage.
  • Have had a stem cell transplant recently.
  • Are on immune-suppressing therapy for graft-versus-host disease after a stem cell transplant.
  • Have had major surgery recently.

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